Status:
COMPLETED
Intranasal Ketamine Versus Intranasal Fentanyl
Lead Sponsor:
Isfahan University of Medical Sciences
Conditions:
Multiple Trauma
Pain, Acute
Eligibility:
All Genders
15-65 years
Phase:
PHASE3
Brief Summary
Abstract Background: Given the inadequate control of pain in patients with injury that refer to the emergency departments, the rapid onset of action of intranasal administration in pain management, an...
Eligibility Criteria
Inclusion
- patients with acute limb trauma, aged 15-65 years, with moderate to severe pain (45 mm; visual analog scale (VAS)), with a GCS score of 15, with the systolic blood pressure of lower than 180 mmHg, diastolic blood pressure of higher than 90 mmHg
- lack of pregnancy
- no history of allergy to ketamine, fentanyl (or opioids), or acetaminophen,
- no history of liver diseases,
- no acute or chronic structural or functional nasal obstruction diseases,
- no history of drug or psychiatric addiction,
- no pain medication within the past four hours,
- no history of heart disease,
- and the presentation of the written consent to participate in the study.
Exclusion
- a decrease in GCS score to less than or equal to 14,
- an elevated systolic blood pressure to higher than 180 mmHg,
- a decreased diastolic blood pressure to less than 80 mmHg,
- inability to understand the VAS pain rating system,
- symptoms of acute heart disease and respiratory depression (respiratory rate \<8 / min),
- and the patient's dissatisfaction to continue the cooperation in study
Key Trial Info
Start Date :
April 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 15 2018
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT04414800
Start Date
April 1 2017
End Date
April 15 2018
Last Update
June 4 2020
Active Locations (1)
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1
Al-Zahra University Hospital
Isfahan, Iran, 8138938728